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A randomized controlled trial study on the development of a social tool based on a multimodal predictive model and its preventive effect on female knee osteoarthritis

A randomized controlled trial study on the development of a social tool based on a multimodal predictive model and its preventive effect on female knee osteoarthritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085464
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-15
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis in women

Interventions

Cohort study group:No
Routine intervention group:Regular verbal and written guidance
APP intervention group:Using an APP for intervention guidance

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Female patients in the outpatient Department of Osteoarthrosis, Peking University Shenzhen Hospital. 2. Between 45 and 55 years old. 3. Body mass index between 20-35 kg/m2. 4. K-L grade of knee joint is less than grade 2. 5. WOMAC score is less than 10 points. 6. The knee resting or exercise VAS score was less than or equal to 3 points, and the pain was sporadic. 7. Multimodal prediction models predict the risk of knee osteoarthritis in postmenopausal women as high-risk patients. 8. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Women with history of knee surgery, history of knee infection, history of knee trauma. 2. Women with knee joint stiffness and ankylosis. 3. Patients with muscle strength grade 3 and below. 4. Women with a long history of contraceptive use. 5. Women with gynecological tumors. 6. Women with chronic metabolic diseases such as diabetes. 7. Women with language and intellectual disabilities who cannot complete the scale detection and examination required by the project. 8. Women with central or peripheral neuropathy affecting normal walking and functional exercise. 9. Women with previous digestive tract ulcers. 10. Women who, for various reasons, were unable to complete the study.

Design outcomes

Primary

MeasureTime frame
Incidence rate of knee osteoarthritis;Knee joint ortho X-ray K-L grade 2 or above;

Secondary

MeasureTime frame
Changes in the joint space between the medial or lateral compartments of the knee joint from baseline on X-rays of the knee joint in an upright position;VAS score under resting and exercise conditions;WOMAC score;Measurement of quadriceps muscle strength;SF-36 score;Serum biomarkers;

Countries

China

Contacts

Public ContactDeli Wang

Peking University Shenzhen Hospital

wangdelinavy@163.com+86 188 2346 3328

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026